Form 8-K

8-K — InspireMD, Inc.

Accession: 0001493152-26-028221

Filed: 2026-06-11

Period: 2026-06-11

CIK: 0001433607

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date

of Report (Date of earliest event reported): June 11, 2026

InspireMD,

Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-35731

26-2123838

(State

or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS

Employer

Identification No.)

6303

Waterford District Drive, Suite 215

Miami,

Florida 33126

6744832

(Address

of principal executive offices)

(Zip

Code)

Registrant’s

telephone number, including area code: (888) 776-6804

(Former

name or former address, if changed since last report.)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under

any of the following provisions:

☐

Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities

registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common

Stock, $0.0001 par value per share

NSPR

The

Nasdaq Capital Market

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405

of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item

7.01. Regulation FD Disclosure.

June 11, 2026, InspireMD, Inc. (the “Company”) issued a press release titled “InspireMD Announces 30-Day Results from

the CGUARDIANS II Clinical Trial of the CGuard Prime 80 cm Implant for Use in TCAR Procedures.” A copy of the press release is

furnished herewith as Exhibit 99.1 to this Form 8-K and is incorporated by reference in this Item 7.01.

accordance with General Instruction B.2 of Form 8-K, the information in this Form 8-K that is furnished pursuant to this Item 7.01, including

Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as

amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference

into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as

shall be expressly set forth by specific reference in such filing.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit

Number

Description

99.1

Press Release, dated June 11, 2026

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

INSPIREMD,

INC.

Date:

June

11, 2026

By:

/s/

Marvin Slosman

Name:

Marvin

Slosman

Title:

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

InspireMD

Announces 30-Day Results from the CGUARDIANS II Clinical Trial of the CGuard Prime 80 cm Implant for Use in TCAR Procedures

PMA

supplement under FDA review with potential approval in H2 2026, potentially expanding the Company’s addressable market to include

TCAR in addition to CAS carotid stenting procedures

Miami,

FL — June 11, 2026 – InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer

of the CGuard® Prime carotid stent system for the prevention of stroke, today announced 30-day outcomes from the CGUARDIANS

II clinical trial of the CGuard Prime 80cm implant for use in transcarotid artery revascularization (TCAR) procedures. InspireMD anticipates

potential approval of the CGuard Prime 80 cm stent implant in the second half of this year.

Key

30-day outcomes observed in the CGUARDIANS II trial include:

● Acute

device success was achieved in 100% (50/50) of patients;

● No

deaths, strokes, or myocardial infarctions were reported within 30 days;

● No

stent thrombosis was observed within 30 days;

● Complete

stent patency observed at 30 days in evaluable subjects.

Dr.

Patrick J. Geraghty, professor of surgery and radiology at Washington University School of Medicine in St. Louis and co-lead investigator

of the CGUARDIANS II study, commented, “The 30-day results observed in the CGUARDIANS II trial suggest that the CGuard Prime 80

cm stent may deliver exceptional safety and efficacy when used with a TCAR approach. Notably, the 100% acute device success rate with

zero major adverse events has the potential to make CGuard Prime the gold standard implant for high-risk patients undergoing TCAR procedures.

I look forward to incorporating it into my own practice, if approved.”

“We

believe the 30-day CGUARDIANS II results represent a significant achievement in our quest to tap into the large and growing TCAR market,”

said Marvin Slosman, CEO of InspireMD. “Together with our recently initiated CGUARDIANS III clinical trial of our proprietary SwitchGuard

neuroprotection system, we potentially have line-of-sight to offering the full TCAR toolkit, subject to regulatory review and approval,

leveraging our best-in-class CGuard Prime Carotid Stent System with its unmatched clinical outcomes, for the more than 35,000 TCAR procedures

that are performed in the U.S. every year.”

CGUARDIANS

II is a prospective, multi-center, single-arm pivotal study that enrolled 50 patients across 11 trial sites. The objective of the study

is to evaluate acute device success and technical success of the CGuard Prime 80 cm when used in conjunction with the FDA-cleared ENROUTE

TCAR neuro-protection system in patients considered at high risk for adverse events from carotid endarterectomy.

Regulatory

Disclaimer: The CGuard Prime Carotid Stent System 80 cm is an investigational device in the United States and is limited by federal law

to investigational use. InspireMD submitted a Premarket Approval (PMA) Supplement to the U.S. Food and Drug Administration (FDA) which

is currently under review.

About

InspireMD, Inc.

InspireMD

seeks to utilize its proprietary MicroNet ™ mesh technology to make its products the industry standard for carotid stenting by

providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on Nasdaq under

the ticker symbol NSPR. We routinely post information that may be important to investors on the Company’s website. For more information,

please visit www.inspiremd.com.

Forward-looking

Statements

This

press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements

regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future

financial performance, strategies, expectations, competitive environment and regulation. Such statements may be preceded by the words

“intends,” “may,” “will,” “plans,” “expects,” “anticipates,”

“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”

“potential”, “scheduled” or similar words. In particular, forward-looking statements in this press release include

expectations regarding potential FDA approvals for CGuard Prime Carotid Stent System 80 cm implant for use in TCAR procedures. Forward-looking

statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks

and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual

results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include,

without limitation, risks and uncertainties associated with the Company’s history of recurring losses and negative cash flows from

operating activities, significant future commitments and the uncertainty regarding the adequacy of its liquidity to pursue its complete

business objectives, and substantial doubt regarding its ability to continue as a going concern; the Company’s need to raise additional

capital to meet its business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute

out stockholders’ ownership interests; the clinical development, commercialization and market acceptance of the Company’s

products; whether the clinical trial results for the Company’s products will be predictive of real-world results; an inability

to secure and maintain regulatory approvals for the sale of the Company’s products; negative clinical trial results or lengthy

product delays in key markets; the Company’s ability to maintain compliance with the Nasdaq listing standards; the Company’s

ability to generate significant revenues from its products; estimates of the Company’s expenses, future revenues, capital requirements

and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the ongoing commercial

launch of its products; the Company’s dependence on a single manufacturing facility and its ability to comply with stringent manufacturing

quality standards and to increase production as necessary; the risk that the data collected from the Company’s current and planned

clinical trials may not be sufficient to demonstrate that its technology is an attractive alternative to other procedures and products;

intense competition in the Company’s industry, with competitors having substantially greater financial, technological, research

and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than it does; entry

of new competitors and products and potential technological obsolescence of the Company’s products; inability to carry out research,

development and commercialization plans; loss of a key customer or supplier; technical problems with the Company’s research and

products and potential product liability claims; product malfunctions; price increases for supplies and components; whether access to

the Company’s products is achieved in a commercially viable manner and whether its products receive adequate reimbursement by governmental

and other third-party payers; the Company’s efforts to successfully obtain and maintain intellectual property protection covering

its products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel

and other foreign jurisdictions; the fact that the Company conducts business in multiple foreign jurisdictions, exposing it to foreign

currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and

political and economic instability in each jurisdiction; security, political and economic instability in the Middle East that could harm

the Company’s business, including due to the current security situation in Israel; current or future unfavorable economic and market

conditions and adverse developments with respect to financial institutions and associated liquidity risk; and changes in tariffs, trade

barriers, price and exchange controls and other regulatory requirements and the impact of such policies on the Company, its customers

and suppliers, and the global economic environment. More detailed information about the Company and the risk factors that may affect

the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission

(SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders

are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation

to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor

Contacts:

Jeff

Warren

LifeSci

Advisors

jwarren@lifesciadvisors.com

investor-relations@inspiremd.com

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